Our Commercial Scale Protein Drug Manufacturing Facility
This state-of-art facility is equipped with two 2,000 L production lines and can be upgraded to 12 of 2,000 L lines. This facility was designed for PIC/S and international GMP compliance. The implementation of FlexFactory® Single-Use Process Technology (GE Healthcare) is flexible and can be easily switched between batches. Its automatic central monitoring system integrates cell culture, buffer solution injection, and protein purification, optimizing the safety of the product and efficiency of the manufacturing process.
Located in Hukou, Hsinchu County, in Taiwan, this pilot plant boasts two 150 L mammalian cell culture–based production systems for protein drug API. The plant obtained approval from Taiwan FDA GMP inspection in October 2007, followed up by GMP inspections in February 2009 and November 2011. This plant has completed production for 15 lots of protein/mAbs drug products for pre-clinical and clinical studies.
The proprietary integrated technologies of UBP, including high-yield cell line construction, cell culture and a purification process, physicochemical and biochemical characterization, high -concentration protein drug formulation, animal pharmacology and pharmacokinetic studies: all in our world-class research and development laboratories.